Europe okays Novo Nordisk diabetes combo Xultophy

The European Commission has granted marketing authorisation for Novo Nordisk’s new combination treatment Xultophy.

Xultophy is a once-daily single injection combination of Tresiba (insulin degludec) and Novo’s blockbuster Victoza (liraglutide). It is indicated for the treatment of adults with type 2 diabetes in combination with oral glucose-lowering drugs when these alone or combined with basal insulin do not provide adequate glycaemic control.

The Danish major noted that for people uncontrolled on basal insulin therapy, Xultophy has demonstrated a significant reduction in HbA1C of 1.9% with a mean weight loss of 2.7 kg and a low rate of hypoglycaemia comparable to that of Tresiba, which has yet to get US approval.

The company expects to resubmit Tresiba for the green light across the Atlantic in mid-2015 as a cardiovascular outcomes trial requested by the Food and Drug Administration is progressing quicker than scheduled. It is already approved in Europe.

As for Xultophy, Novo chief scientic officer Mads Krogsgaard Thomsen claimed that it “represents a new paradigm with the potential to transform how type 2 diabetes is treated”. The combo was approved in Switzerland last week and the company expects to launch in the first European Union countries in the first half of 2015.